FDA 510(k)

FLEXI-PORT™ Power Injectable Implantable Port

Número K: K260916 · 2026-06-17

Data da decisão2026-06-17

Código do produtoLJT

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

FLEXI-PORT™ Power Injectable Implantable Port is the device name listed in this FDA 510(k) record. The listed applicant is Portal Access, Inc.. It received FDA 510(k) clearance on 2026-06-17 under 510(k) number K260916. The device is classified under product code LJT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FLEXI-PORT™ Power Injectable Implantable Port?

FLEXI-PORT™ Power Injectable Implantable Port is a medical device that received FDA 510(k) clearance on 2026-06-17. The listed applicant is Portal Access, Inc.. The 510(k) number is K260916.

When did FLEXI-PORT™ Power Injectable Implantable Port receive FDA 510(k) clearance?

FLEXI-PORT™ Power Injectable Implantable Port received FDA 510(k) clearance on 2026-06-17, under 510(k) number K260916.

Who is the listed applicant for FLEXI-PORT™ Power Injectable Implantable Port?

The FDA 510(k) record lists Portal Access, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLEXI-PORT™ Power Injectable Implantable Port?

The FDA product code for FLEXI-PORT™ Power Injectable Implantable Port is LJT.

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Dispositivos Relacionados (Código: LJT)

K252478Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable PortBard Access Systems, Inc.K251253PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable PortBard Access Systems, Inc.K242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable PortsBard Access Systems, Inc.K232737PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable Port; PowerPort™ isp M.R.I.™ ECG Enabled Implantable Port; PowerPort™ Slim ECG Enabled Implantable PortBard Peripheral Vascular, Inc.K190559SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsAngioDynamics, Inc.K181446Bard Power-Injectable Implantable Ports (PowerPorts®)C.R. Bard, Inc.

Fonte oficial

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